MAUDE Adverse Event Report: ST. JUDE MEDICAL ENGAGE INTRODUCER; INTRODUCER, CATHETER

Model Number	C408507
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a coronary angiogram procedure, there was leaking noted while using an engage introducer.The physician stated that it does not happen with every introducer but estimates about every 1 in 5-8 cases there is leaking noted.It was confirmed that no leaking was noted prior to catheter use.The procedure was completed with no adverse patient consequences.There have been additional complaints about engage 6f introducers leaking during cases.The leaking has not occurred with every introducer used; however, 3 cardiologists have experienced this issue.Leaking occurred with 4 introducers used last week.It is unknown if the issue is with this specific lot or not.The last 4 unopened introducers with lot number 8846300 were obtained to returned for investigation.All procedures were completed with no adverse patient consequences by exchanging the introducer.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported leak could not be conclusively determined.

• Brand Name: ENGAGE INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19556038
• Report Number: 3005334138-2024-00241
• Device Sequence Number: 4733687
• Product Code: DYB
• UDI-Device Identifier: 05414734030465
• UDI-Public: (01)05414734030465(10)8846300(17)260131
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: C408507
• Device Catalogue Number: C408507
• Device Lot Number: 8846300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENGAGE INTRODUCER
• Patient Sex: Unknown